On March 30, 2023 Checkpoint Therapeutics, Inc. ("Checkpoint") (Nasdaq: CKPT), a clinical-stage immunotherapy and targeted oncology company, reported financial results for the full-year ended December 31, 2022, and recent corporate highlights (Press release, Checkpoint Therapeutics, MAR 30, 2023, View Source [SID1234629653]).
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James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, "The past year was a momentous one for Checkpoint, and we began 2023 with the submission of our Biologics License Application ("BLA") to the U.S. Food and Drug Administration ("FDA") seeking approval of cosibelimab, our investigational anti-PD-L1 antibody, as a treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or radiation. Our BLA submission was subsequently accepted for filing and is under active review with a Prescription Drug User Fee Act ("PDUFA") goal date of January 3, 2024."
"This initial indication for cosibelimab represents a potential $1.6 billion U.S. market opportunity," continued Oliviero. "With its unique mechanism of action and compelling safety profile, we believe cosibelimab, if approved, would be uniquely positioned to provide an important new treatment option for cSCC patients who are currently underserved by available therapies."
2022 and Recent Corporate Highlights:
Checkpoint submitted a BLA to the FDA seeking approval of cosibelimab in January 2023. In March 2023, the FDA accepted for filing the BLA for cosibelimab and set a PDUFA goal date of January 3, 2024. In its BLA filing acceptance letter, the FDA indicated that no potential filing review issues have been identified, and that an advisory committee meeting to discuss the application is not currently planned.
In January 2022, Checkpoint announced positive top-line results from its registration-enabling clinical trial evaluating the safety and efficacy of cosibelimab, administered as a fixed dose of 800 mg every two weeks in patients with metastatic cSCC. The study met its primary endpoint, with cosibelimab demonstrating a confirmed objective response rate ("ORR") of 47.4% (95% CI: 36.0, 59.1) based on independent central review of 78 patients enrolled in the metastatic cSCC cohort using Response Evaluation Criteria in Solid Tumors version 1.1 criteria.
In May 2022, Checkpoint announced that it received Pediatric Investigation Plan product-specific waivers from the European Medicines Agency and the U.K. Medicines & Healthcare products Regulatory Agency for cosibelimab in cSCC. The waivers remove the requirement to conduct pediatric clinical studies to support cosibelimab marketing authorization applications in Europe.
In June 2022, Checkpoint announced that the top-line results of its pivotal trial of cosibelimab in metastatic cSCC were presented at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Data highlights presented included confirmed ORR by independent central review in the modified intent-to-treat population of 48.7% (95% CI, 37.0-60.4), and 13.2% of patients achieved a complete response in target lesions. Cosibelimab was generally well tolerated with no unexpected safety signals.
Also in June 2022, Checkpoint announced positive interim results from its pivotal trial of cosibelimab in locally advanced cSCC. As of the March 2022 data cutoff, the confirmed ORR by independent central review in 31 patients was 54.8% (95% CI: 36.0, 72.7).
In July 2022, Checkpoint successfully completed two pre-BLA meetings with the FDA (chemistry, manufacturing and controls and clinical/non-clinical). Based upon favorable interactions with the agency, the January 2023 BLA submission included both the metastatic and locally advanced cSCC indications. Checkpoint also reached agreement with the FDA on all key aspects discussed regarding the content of the BLA submission.
In December 2022, Checkpoint completed a registered direct offering priced At-the-Market under Nasdaq rules, for total gross proceeds of approximately $7.5 million.
In February 2023, Checkpoint completed another registered direct offering priced At-the-Market under Nasdaq rules and a concurrent private placement of two series of warrants to purchase Checkpoint common stock, for total gross proceeds of approximately $7.5 million.
Financial Results:
Cash Position: As of December 31, 2022, Checkpoint’s cash and cash equivalents totaled $12.1 million, compared to $54.7 million at December 31, 2021, a decrease of $42.6 million. This cash position is not reflective of the registered direct offering closed in February 2023 for total gross proceeds of approximately $7.5 million.
R&D Expenses: Research and development expenses for the year ended December 31, 2022, were $49.8 million, compared to $48.5 million for the year ended December 31, 2021, an increase of $1.3 million. Research and development expenses for the year ended December 31, 2022 included $2.8 million of non-cash stock expenses, compared to $7.3 million in non-cash stock expenses for the year ended December 31, 2021.
G&A Expenses: General and administrative expenses for the year ended December 31, 2022, were $8.7 million, compared to $8.5 million for the year ended December 31, 2021, an increase of $0.2 million. General and administrative expenses for the year ended December 31, 2022 included $2.5 million of non-cash stock expenses, compared to $3.5 million in non-cash stock expenses for the year ended December 31, 2021.
Net Loss: Net loss attributable to common stockholders for the year ended December 31, 2022 was $62.6 million, or $7.09 per share, compared to a net loss of $56.7 million, or $7.45 per share, for the year ended December 31, 2021.